Digitally Enhanced Stepped-Care for Depression in Primary Care

Digitally Enhanced Stepped-Care for Depression in Primary Care: A Pilot Randomized Clinical Trial to Support Scalable Deployment and Commercialization

This pilot, three-arm randomized clinical trial (N=40; 2:1:1) will evaluate the feasibility and preliminary efficacy of a digitally enhanced stepped-care approach for depression treatment in primary care. Participants will be randomized to: (1) stepped-care beginning with a self-guided Behavioral Activation app (Moodivate), with stepping to clinician-delivered telebehavioral health Behavioral Activation at Week 2 based on app engagement and early PHQ-9 change; (2) telebehavioral health Behavioral Activation; or (3) Moodivate alone. The primary endpoint is feasibility of the stepped-care approach, defined as continued engagement after stepping (≥1 Moodivate use/week for >4 weeks or ≥4 therapy sessions). The secondary endpoint is change in PHQ-9 scores from baseline through Week 12. The study will be conducted within MUSC Primary Care clinics across South Carolina using remote screening, e-consent, and REDCap assessments.

Inclusion Criteria:

• elevated depression symptoms (score of >=10 on the PHQ-9)
• age >=18 years
• owns an iOS or Android smartphone
• willing to use Moodivate
• willing to engage in telehealth depression treatment
• access to email or text messaging (for assessments)
• English fluency

Exclusion Criteria:

• current receipt of psychosocial depression treatment (e.g., individual or group therapy)
• current suicidal ideation, defined as a response >=1 ("several days") on PHQ-9 item nine
• does not live in the state of South Carolina